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BAYH-DOLE: TALES FROM THE FRONT ALICE O. MARTIN, Ph.D., J.D. PARTNER BARNES & THORNBURG, LLP

BAYH-DOLE: TALES FROM THE FRONT ALICE O. MARTIN, Ph.D., J.D. PARTNER BARNES & THORNBURG, LLP. BASIS FOR THE PRESENTATION. QUESTIONS FOR DISCUSSION WERE PRESENTED TO INTERVIEWEES FROM A SMALL GROUP OF TECH TRANSFER OFFICES, INDUSTRY (SMALL, LARGE), AND INVESTORS.

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BAYH-DOLE: TALES FROM THE FRONT ALICE O. MARTIN, Ph.D., J.D. PARTNER BARNES & THORNBURG, LLP

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  1. BAYH-DOLE: TALES FROM THE FRONTALICE O. MARTIN, Ph.D., J.D.PARTNERBARNES & THORNBURG, LLP

  2. BASIS FOR THE PRESENTATION QUESTIONS FOR DISCUSSION WERE PRESENTED TO INTERVIEWEES FROM A SMALL GROUP OF TECH TRANSFER OFFICES, INDUSTRY (SMALL, LARGE), AND INVESTORS

  3. IN WHAT CONTEXT HAVE YOU ENCOUNTERED BAYH-DOLE? • RECEIVED FEDERAL FUNDING • UNIVERSITIES • SPIN-OFFS, SBIRS • NEGOTIATED LICENSES WITH ENTITIES WHO RECEIVED FEDERAL FUNDING • OTHER OR BOTH

  4. WHAT HAVE BEEN THE POSITIVE ASPECTS OF BAYH-DOLE IN YOUR AREA? • SOME INTERVIEWEES GREW UP WITH BAYH-DOLE - NO BASIS FOR COMPARISON! • MADE INVENTIONS USEFUL TO THE PUBLIC • UNIVERSITIES MORE PART OF COMMUNITY • REVENUE STREAM, SETS MILESTONES • UNIVERSITIES SHARE PROFITS WITH INVENTORS • ENCOURAGED FACULTY ENTREPRENEURS • STRENGTHEN CONTACTS BETWEEN INVENTORS AND INVENTION

  5. WHAT HAVE BEEN THE POSITIVE ASPECTS OF BAYH-DOLE IN YOUR AREA? • ATUM, LES • CREATED ENVIRONMENTS FAVORABLE FOR SMALL COMPANIES, SPINOFFS • PHARMA TONING DOWN R&D; FUNDING UNIVERSITIES, SMALL COMPANIES • INCREASED INCENTIVE TO INVEST IN PIONEER (EARLY STAGE) INVESTMENTS

  6. WHAT HAVE BEEN THE NEGATIVE ASPECTS OF BAYH-DOLE IN YOUR AREA? • ANTAGONISTIC FACULTY, PUBLIC • RAISED FACULTY EXPECTATIONS • PUBLIC OFFENDED – TAX DOLLARS FOR RESEARCH • BUREAUCRACY, UNDERSTAFFING = SLOW RESPONSE ADEQUATE MONITORING? • U.S. MANUFACTURING DIFFICULT TO FIND (FOR PRODUCTS SOLD IN U.S.) • UNIVERSITIES BEAR BURDEN OF COSTS • MULTIPLE LAYERS CONTROL • TOO MUCH FOCUS ON PATENTS, LESS ON COMMERCIALIZATION • DOES BAYH-DOLE PERFORMANCE BY UNIVERSITIES AFFECT GETTING GRANTS?

  7. HAS THE DECISION IN STANFORD V. ROCHE HAD ANY IMPACT ON YOUR WORK? • SUPREME COURT: INVENTORS’ RIGHTS TO INVENTIONS NOT AFFECTED BY BAYH-DOLE • TITLE TO INVENTION: “… CONCEIVED OR FIRST ACTUALLY REDUCED TOPRACTICE IN THE PERFORMANCE OF WORK UNDER A FUNDING AGREEMENT” • DUE DILIGENCE BY INVESTORS INCREASED

  8. HAS THE DECISION IN STANFORD V. ROCHE HAD ANY IMPACT ON YOUR WORK? • COMPANIES WANT GUARANTIES • REVISED ASSIGNMENT POLICIES • BAYH-DOLE LANGUAGE REGARDING TITLE NOT CLEAR • HARD TO DECIDE WHERE AND WHEN CONCEPTION IF MULTIPLE INVENTORS

  9. “OWNERSHIP OR STEWARDSHIP?” GEN, FEB. 1, 2012 “UNIVERSITIES NEED TO RECONSIDER PATENT POLICIES IN LIGHT OF STANFORD V. ROCHE RULING” • MANY TECH TRANSFER OFFICES TRYING TO END “FACULTY-LED INVENTION MANAGEMENT” • UNIVERSITIES POLICIES REQUIRE FACULTY ET AL. TO ASSIGN RIGHTS • BAYH-DOLE BLAMED FOR REQUIRING FACULTY TO ASSIGN FEDERALLY FUNDED INVENTIONS ANSWER • PATENT LAW DEFINES INVENTORSHIP • EMPLOYER/EMPLOYEE RELATIONSHIP CONVEYS RIGHTS • BAYH-DOLE NOT AUTOMATIC “TITLE-VESTING” • INVENTORS WHO RETAIN TITLE STILL SUBJECT TO THE BAYH-DOLE ACT • FACULTY RARELY CAN COMMERCIALIZE

  10. DO YOU THINK THE AIA WILL HAVE ANY IMPACT ON IMPLEMENTATION OF BAYH-DOLE? • FIRST TO FILE FORCES EARLIER DECISIONS REGARDING PUBLICATIONS, PROVISIONALS • COVER PAGE PROVISIONALS MUST ENABLE • PUBLICATION MAY BAR FOREIGN FILING • BAYH-DOLE CONTRACTORS MAY NOT BE ABLE TO ASSERT RIGHTS. • COMPANIES MAY FUND R&D AT UNIVERSITIES, SMALL BIOTECHS EARLIER

  11. WHAT SUGGESTIONS DO YOU HAVE TO IMPROVE BAYH-DOLE? • MORE RESPONSIVE, EASIER EDISON REPORTING • MORE OVERSIGHT BY GOVERNMENT e.g. PRICES TO CONSUMERS • BETTER PUBLIC RELATIONS

  12. DOES THE "MARCH IN RIGHTS" PROVISION AFFECT YOUR DECISIONS THAT INVOLVE BAYH-DOLE? • NEVER USED FOR U.S. LICENSES • MULTINATIONALS EXPECT • PROBLEM FOR FOREIGN LICENSEES (COMPANIES & COUNTRIES) • INTERNATIONAL AGREEMENT (IIA) • FOLLOW-ON WORK • NOT ALL BAYH-DOLE

  13. EXCLUSIVE V. NON-EXCLUSIVE LICENSING COMPLICATIONS • TECH TRANSFER ACT, 1986, EXCLUSIVE LICENSING • TRICKY WITH SPONSORED PROJECT RESEARCH – “COMMINGLING WITH FEDERAL FUNDS” • MAY WANT CERTIFICATION NO COMMINGLING SPONSORED PROJECT RESEARCH & FEDERAL FUNDS • CONFLICT MANAGEMENT NEEDED – FACULTY COMMERCIAL INTERESTS • NIH GUIDELINES • EXEMPT RESEARCH TOOLS? • BEST PRACTICES • POOLING

  14. THANK YOU. ALICE O. MARTIN, PH.D., J.D. ALICE.MARTIN@BTLAW.COM

  15. Thank You! Sponsor: Program Coordinator: Andrew B. Freistein Moderator: Lynn C. Tyler

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